The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethibond Excel Valve Loop Suture.
| Device ID | K003070 |
| 510k Number | K003070 |
| Device Name: | ETHIBOND EXCEL VALVE LOOP SUTURE |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Gregory R Jones |
| Correspondent | Gregory R Jones ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-02 |
| Decision Date | 2000-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031462400 | K003070 | 000 |
| 20705031462264 | K003070 | 000 |
| 20705031462257 | K003070 | 000 |
| 20705031462240 | K003070 | 000 |
| 20705031462233 | K003070 | 000 |
| 20705031462226 | K003070 | 000 |
| 20705031462219 | K003070 | 000 |
| 20705031462202 | K003070 | 000 |
| 30705031239788 | K003070 | 000 |
| 30705031239771 | K003070 | 000 |
| 10705031035904 | K003070 | 000 |
| 20705031462271 | K003070 | 000 |
| 20705031462288 | K003070 | 000 |
| 20705031462394 | K003070 | 000 |
| 20705031462387 | K003070 | 000 |
| 20705031462370 | K003070 | 000 |
| 20705031462363 | K003070 | 000 |
| 20705031462356 | K003070 | 000 |
| 20705031462349 | K003070 | 000 |
| 20705031462332 | K003070 | 000 |
| 20705031462325 | K003070 | 000 |
| 20705031462318 | K003070 | 000 |
| 20705031462301 | K003070 | 000 |
| 10705031031005 | K003070 | 000 |